FDA asks for internal review of approval process for Alzhiemer’s drug

The U.S. Food and Drug Administration is asking for an internal review of its own approval process that gave a greenlight to a drug to treat Alzhiemer’s, a move that could shed more light on the controversial chain of decision-making that led to the drug’s being okayed for use.

The FDA last month approved drug company BioGen’s product Aduhelm, the first medicine greenlit in the U.S. to slow the cognitive decline of those living with Alzhiemer’s. 

Yet that decision was shrouded in controversy: The approval went against the advice of an outside panel of FDA experts and even led to the resignation of several of those experts in protest. 

Acting FDA Commissioner Janet Woodcock on Friday revealed that she was requesting that Acting Health and Human Resources Inspector General Christi Grimm conduct "an independent review and assessment of interactions between representatives of Biogen and the FDA" during the process that led to the drug’s approval. 

Woodcock said the investigation should seek to "determine whether any of those interactions were inconsistent with FDA policies and procedures." 

"There continue to be concerns raised…regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process," she noted. 

Woodcock vowed that the FDA will "fully cooperate" with any investigation.